FDA 483 - ONTEL PRODUCTS CORPORATION - May 29, 2025

An FDA inspection of ONTEL PRODUCTS CORPORATION, a specification developer in Fairfield, NJ, revealed significant deficiencies in their quality system. The firm failed to establish procedures for purchasing controls and supplier evaluation. Additionally, the company did not implement Unique Device Identifiers (UDI) on medical device labels and neglected to submit required device information to the Global Unique Device Identification Database (GUDID).